Kornimate/medical-research-clean huggingface dataset:
single photon emission computed tomography/computed tomography with pentavalent 99mtc dimercaptosuccinic acid in patients with brain glioma; correlation with idh mutation

Conditions: Brain Glioma

Summary: the aim of this study is to evaluate the correlation between degree of 99mtc-dmsa (v) uptake at spect/ct and idh mutation in patients with brain glioma.

every year, nearly100,000 people worldwide are diagnosed as having brain gliomas. although it comprises \<1% of all newly diagnosed cancers, brain glioma is associated with substantial mortality and morbidity. gliomas are intrinsic brain tumors that originate from neuroglial progenitor cells. conventional therapies, including surgery, chemotherapy, and radiotherapy, have achieved limited improvements in the prognosis of glioma patients. radiation therapy to the brain may lead to postradiation injury which typically occurs within the first 3 to 12 months after radiotherapy but it was reported up to several years and even decades later. the clinical picture of radiation necrosis (rn) is variable and may include seizures, headache, personality changes, and neurologic deficits. these symptoms mimic tumor recurrence and differentiation between the two entities clinically or even by conventional radiological modalities is difficult but is necessary because the two conditions have different treatment modalities and prognosis. spect has the advantages of being widely available and not expensive. multiple spect tracers have been explored. of them thallium-201 and 99 mtc-mibi are, possibly, the most extensively discussed. the main disadvantage of 201tl is the lower spatial resolution, relatively large radiation dose, and the reported high false positive results. normal uptake of mibi in the choroid plexus may be confounding for assessing tumors around the ventricles. pentavalent 99mtc dimercaptosuccinic acid (99mtc (v) dmsa), is a nonspecific tumor targeting spect radiotracer, that has been used for imaging of various tumors including lung and breast carcinoma. however, to date, scarce reports discussed the utility of dmsa-v in patients with glioma. isocitrate dehydrogenase (idh) enzymes, of which there are three isoforms, are essential enzymes that participate in several major metabolic processes, such as the krebs cycle, glutamine metabolism, lipogenesis and redox regulation. major advances in cancer genetics over the past decade have revealed that the genes encoding idhs are frequently mutated in a variety of human malignancies, including gliomas, acute myeloid leukaemia, cholangiocarcinoma, chondrosarcoma and thyroid carcinoma.

Eligibility criteria:
inclusion criteria: * patients with a pathologically proven glioma. • patients conscious to provide informed consent exclusion criteria: * pregnant women. * severely ill patients and those with disturbed conscious level, * patients who were judged that they cannot lie down comfortably without movement for at least 20 min
eeg personalized transcranial magnetic stimulation (etms) for post-traumatic stress disorder

Conditions: Stress Disorders, Post-Traumatic

Summary: this is an open-label safety pilot study of the electroencephalogram (eeg) transcranial magnetic stimulation (etms) treatment for post-traumatic stress disorder (ptsd). the recruitment goal is 30 participants who are united states military veterans or first responders (e.g., firefighters, police, paramedics, etc.). the study includes an eeg recording in order to determine the optimal treatment parameters for the etms system, followed by 10 in-office visits that take place over 21 total days. two etms treatment sessions are administered during each office visit.

etms-ptsd-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. the study is intended to evaluate the safety aspects of etms in the target population. a maximum of 400 individuals will be screened in order to achieve the recruitment goal. the total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 7 months. participants will be either veterans or first responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. participants may be male or female of any racial/ethnic background who meet the eligibility criteria. participants will be recruited from the general public, and from veterans and first responder organizations. the primary outcome for the study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study.

Eligibility criteria:
inclusion criteria: * willing and able to consent to participate in the study via signed informed consent * age 22 - 65 years * provisional diagnosis of ptsd * positive identification as either a veteran, or first responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel) exclusion criteria: * uncontrolled medical, psychological or neurological condition * pregnant, or female unwilling to use effective birth control during the course of the trial * metal objects implanted in the head * past exposure to metal fragments or other metal sources in the head and neck * current participation in any interventional research protocol * history of any type of electroconvulsive therapy (ect) or tms * history of stroke or intracranial lesion, or increased intracranial pressure * history or epilepsy or seizure * family history of epilepsy or seizure in 1st degree relative.

Keywords: ptsd veterans first responders
study 2: learning new words from overhearing in children with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: the goal of this research is to explore abilities to learn word meanings from overheard conversations in children with asd (and, as a control, typically developing children). specific aim 2 (experiment 2): determine whether children with asd can learn from addressed and overheard teaching via videoconferencing. the investigators will use a similar procedure to study 1, except that both overheard and directed teaching will take place on video.


Eligibility criteria:
inclusion criteria: children with or without a diagnosis of asd between 18 to 71 months of age exclusion criteria: native language is not english born premature (\< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than asd that affect language or cognition (excepting psychiatric conditions often comorbid with asd such as adhd) has a history of photosensitive epileptic seizures
comparative study of clinical endpoint in dmd: handheld myometry (hhm) versus cinrg quantitative measurement system (cqms)

Conditions: Duchenne Muscular Dystrophy

Summary: the aim of the proposed research is to compare two commonly used pediatric strength testing measures: handheld myometry (hhm) and cinrg quantitative measurement system (cqms), with the goal of identifying a sensitive and valid tool for measuring muscle strength in children with dmd. the data obtained from this study will be used to make recommendations for strength measurement endpoints in prospective muscular dystrophy trials and provide more reliable and accurate recommendations in the clinic for strength assessment. this study will be performed at six participating sites in the cooperative international neuromuscular research group (cinrg).

we propose to compare the reliability of cqms vs. hhm in the dmd population. the importance of this study is to be able to compare the results of clinical trials done by different networks using distinct strength endpoints. if results indicate a distinct difference in reliability of one tool over the other, a standardized tool could be established for research groups throughout the world to interpret strength in the context of clinical trials. if the results indicate minor differences then it would be possible to interpret and compare/contrast strength measurements used in different studies. understanding the relationship between the hhm vs cqms will help us examine other surrogate measures capable of predicting functionality that are based on strength measurements.

Eligibility criteria:
participants should meet the following criteria: 1. confirmed clinical and molecular diagnosis of dmd 2. 6- 18 years of age 3. ability to follow 2 step instructions 4. ability to transfer to and from the wheelchair-mat with moderate assistance defined as no greater than 75% assistance. 5. signed informed consent of parental or legal guardian(s) is required for participants. assent from children 7-18 years old may also required. exclusion criteria: participants must confirm: 1. no surgical procedures were performed ≤ 8 weeks before study procedures. 2. no musculoskeletal injuries were experienced ≤ 8 weeks before study procedures. 3. investigator assessment that patient or parent/legal guardian are not willing or able to comply with study procedures.

Keywords: neuromuscular disease duchenne muscular dystrophy dmd strength assessment cinrg quantitative measurement system cqms hand held myometry hhm
mucous fistula refeeding reduces the time from enterostomy closure to full enteral feeds ("muc-fire" trial)

Conditions: Enterostomy

Summary: the primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.

enterostomies in children may be created for different reasons. during the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. therefore it does not contribute to the resorption of enteral contents. as a consequence these children need additional parenteral nutrition. due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (mfr) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this treatment.the aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. we hypothesize that mfr between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

Eligibility criteria:
inclusion criteria: 1. infants \< 366 days, 2. ileostomy / jejunostomy, 3. double loop enterostomies and split enterostomies (with mucous fistula) 4. signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child exclusion criteria: 1. resection of ileocecal valve, 2. colostomy, 3. small bowel atresia, 4. multiple ostomies (more than just an enterostomy and a mucous fistula), 5. chromosomal abnormalities (if known at the time of randomization), 6. hirschsprung's disease, 7. participation in another drug-intervention study 8. intestinal perforation due to a hemodynamic heart defect

Keywords: infants necrotizing enterocolitis (nec) focal intestinal perforation (fip) enterostomy creation bowel reanastomosis enteral feeding caloric intake parenteral nutrition complication rate reduction of hospital expenses length of hospital stay refeeding
a randomized controlled trial on wound irrigation in open appendectomy.

Conditions: Appendicitis

Summary: a large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution. the present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional ssi after open appendectomy for acute appendicitis. we postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional ssi by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the mcburney's incision.


Eligibility criteria:
inclusion criteria: * the study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix. exclusion criteria: * patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.
collection and measurement of biomarkers in prostate cancer radiotherapy patients

Conditions: Prostate Cancer

Summary: the purpose of this research study is to learn about: 1) how standard radiation treatment to prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative radiotherapy) may cause changes in mri and pet imaging traits that might be used in the future to predict response. 2) comparison of such mri and pet imaging traits with the number of circulating tumor cells (ctcs) present in the blood prior to treatment and the changes in these counts after treatment. 3) how mri and pet imaging characteristics and changes are related to the expression of genes in the cancer tissue obtained before treatment from prostate biopsy or a prior prostatectomy before treatment. 4) how the response of prostate cancer treatment relates to the imaging and ctc changes.


Eligibility criteria:
inclusion criteria: 1. pathologic confirmation of prostate cancer. 2. any t-stage. 3. by imaging or clinical criteria, any patient with disease staging of n0/n1 and m0/m1. * patients with metastatic disease are encouraged to participate. 4. any gleason score will be eligible. 5. androgen deprivation therapy (adt) is at the discretion of the treating physician, but must be declared as none, short-term, long-term, or extended prior to enrollment. the length is calculated from the lhrh (agonist injection). if adt is planned (based on treating physician preference), the following restrictions apply: * short term adt is defined as ≤ 7 months; * long term adt is defined as \> 7 months and ≤ 36 months; * extended adt is defined as \>36 months (e.g., m1 patients). 6. prostate-specific antigen (psa) ≤100 ng/ml within (+/-) 4 months of signing of consent. if psa was above 100 and drops to \<100 with antibiotics, this is acceptable for enrollment. 7. no previous pelvic radiotherapy. 8. the ability to understand and the willingness to sign a written informed consent document 9. zubrod performance status ≤ 2 (karnofsky or ecog performance status may be used to estimate zubrod): 10. age ≥ 30 at signing of consent. 11. subjects must be planned to receive radiation therapy or to undergo prostatectomy. 12. subjects treated primarily with rt are recommended to have had an mufgbx prior to radiation treatment.

Keywords: circulating tumor cells ctcs androgen deprivation therapy adt
incidence of second primary malignancies in castration-resistant prostate cancer: an observational retrospective cohort study in the us

Conditions: Prostatic Neoplasms

Summary: this study is conducted to estimate population-based incidence rates of second primary malignancies among patients with crpc similar to those treated with xofigo. these rates will provide context for second primary malignancy incidence rates from the reassure study. furthermore this study aims to provide further information about the documentation of bone metastases in medicare data and the extent of use of only oral androgen deprivation drugs among patients with medicare part d coverage, as well as to estimate overall survival of the study population.

xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (crpc), symptomatic bone metastases, and no known visceral metastatic disease. the long-term safety profile of xofigo is evaluated in the prospective reassure study, which estimates the incidence rates of second primary malignancies in patients with crpc receiving xofigo. to provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with crpc similar to those who are treated with xofigo.

Eligibility criteria:
inclusion criteria: * enrolled in both medicare parts a and b for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments) * primary site code of prostate cancer (international classification of diseases for oncology, third edition \[icd-o-3\] topography code c61.9) in seer data * surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin * evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-t * cohort entry date 01 january 2006 or later * age 65 years or older in the us on the cohort entry date exclusion criteria: * enrollment in an hmo (health maintenance organization) in the year before the cohort entry date * diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date * any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date * any claim for treatment with xofigo on or before the cohort entry date.
brief intervention for drug abusing adolescents

Conditions: Drug Abuse

Summary: the purpose of this clinical trail is to evaluate the efficacy of a brief, cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug abuse (mmda). this school-based initiative employs a collaborative effort between the university of minnesota researchers and the st. paul public schools. this intervention aims to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and problem-solving skills.

the purpose of this clinical trail is to evaluate the efficacy of a brief, cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug abuse (mmda). this school-based initiative employs a collaborative effort between the university of minnesota researchers and the st. paul public schools. this intervention aims to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and problem-solving skills. specifically, we propose a randomized clinical trial to evaluate the efficacy of a cognitive-behavioral therapy on key process and outcome dimensions among school-based youth with mild-to-moderate drug abuse (mmda). the experimental treatment is designated brief cognitive behavioral intervention (bcbi) given its theoretical foundation in stage of change theory used to coordinate modules on rational-emotive therapy and problem solving therapy. bcbi will be compared against a second experimental treatment that consists of bcbi and a single parent session (bcbi+p) and an assessment only condition (control). the importance of clarifying mechanisms in drug treatment research will be explored with respect to a limited number of treatment and individual factors that have emerged as promising mediating and moderating factors, such as cognitive and problem solving factors, parenting practices, and peer group influences.

Eligibility criteria:
inclusion criteria: 1. student at a local school 2. meets dsm-iv criteria for a substance abuse disorder for at least one drug 3. student and parent both agree to participate in the intervention study exclusion criteria: 1. meets criteria for at least one dsm-iv substance dependence disorder 2. meets criteria for a psychotic disorder or a learning disability

Keywords: drug abuse
scancap scandinavian automatic capture study

Conditions: Bradycardia

Summary: the primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with guidant insignia ultra or avt .

currently the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). a decrease in the programmed output can be used to increase the projected battery life or to eliminate diaphragmatic or pectoral muscle stimulation. an increase in programmed output may be required to account for increasing thresholds after lead implantation. the ability of an implanted pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s. the automatic capture feature in the insignia i ultra/avt pacemaker automatically adapts the ventricular pacing output to ensure capture of the ventricle while optimizing the output voltage. the primary objective of this study is to document the success rate of the automatic threshold test in a normal pacemaker patient population by following normal pacemaker follow-up results for 1 year.

Eligibility criteria:
inclusion criteria: * suitable candidate for a insignia i ultra or insignia i avt pacemaker (with a ventricular lead). availability for follow-up at the centre. willingness to participate in this study. age 18 or above, or of legal age to give informed consent as specified by national law. exclusion criteria: * inability or refusal to sign the patient informed consent. known pregnancy. presence of mechanical tricuspid valve